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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K160332
Device Name Stryker SDC3 HD Information Management System with Wireless Device Control Capability
Stryker Endoscopy
5900 Optical Court
San Jose,  CA  95138
Applicant Contact Angela Wong
Stryker Endoscopy
5900 Optical Court
San Jose,  CA  95138
Correspondent Contact Angela Wong
Regulation Number876.1500
Classification Product Code
Subsequent Product Code
Date Received02/08/2016
Decision Date 05/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No